Long-term Follow-up Study for Participants of Kite-Sponsored Interventional Studies Treated With Gene-Modified Cells
- Conditions
- Solid and Hematological Malignancies
- Interventions
- Biological: Anitocabtagene autleucel
- Registration Number
- NCT05041309
- Lead Sponsor
- Kite, A Gilead Company
- Brief Summary
The goal of this clinical study is to learn more about the long-term safety, effectiveness and prolonged action of Kite study drugs, axicabtagene ciloleucel, brexucabtagene autoleucel, KITE-363, KITE-753, KITE-197, and anitocabtagene autoleucel in participants of Kite-sponsored interventional studies.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ENROLLING_BY_INVITATION
- Sex
- All
- Target Recruitment
- 1000
- The individual must have received an infusion of gene-modified cells in a completed Kite-sponsored parent study, has not withdrawn full consent, and has discontinued or completed the post-treatment follow-up period in the parent study, as applicable
- The individual must understand and voluntarily sign an Informed Consent Form (ICF) or an Informed Assent Form prior to any study-related assessments or procedures being conducted
- In the investigator's judgment, the individual is willing and able to complete the protocol-required follow-up schedule and comply with the study requirements for participation
none
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Brexucabtagene Autoleucel (KTE-X19) Brexucabtagene Autoleucel All participants who previously received brexucabtagene autoleucel (KTE-X19) in the parent study will be enrolled in this cohort for long-term follow-up. Axicabtagene Ciloleucel (KTE-C19) Axicabtagene Ciloleucel All participants who previously received axicabtagene ciloleucel (KTE-C19) in the parent study will be enrolled in this cohort for long-term follow-up. Anitocabtagene autleucel Anitocabtagene autleucel All participants who previously received anitocabtagene autleucel in the parent study will be enrolled in this cohort for long-term follow-up. KITE-753 KITE-753 All participants who previously received KITE-753 in the parent study will be enrolled in this cohort for long-term follow-up. KITE-197 KITE-197 All participants who previously received KITE-197 in the parent study will be enrolled in this cohort for long-term follow-up. KITE-363 KITE-363 All participants who previously received KITE-363 in the parent study will be enrolled in this cohort for long-term follow-up.
- Primary Outcome Measures
Name Time Method Percentage of Participants Experiencing Late-onset Targeted Adverse Events (AEs) Up to 15 years Targeted AEs include late-onset targeted AEs suspected to be possibly related to gene-modified cells include neurologic disorders, autoimmune disorders, hematologic disorders, serious infections, and new malignancies.
Percentage of Participants Experiencing Late-onset Targeted Serious Adverse Events (SAEs) Up to 15 years Targeted SAEs include late-onset targeted SAEs suspected to be possibly related to gene-modified cells include neurologic disorders, autoimmune disorders, hematologic disorders, serious infections, and new malignancies.
Height of Pediatric and Adolescent Participants Up to 15 years Weight of Pediatric and Adolescent Participants Up to 15 years Sexual Maturation of Pediatric and Adolescent Participants Assessed by Tanner Pubertal Stage Scale Score Up to 15 years The Tanner Pubertal Stage Scale is a measure of pubertal development (sexual maturation) in children and adolescents with components described for each sex, rated separately on a scale of stage one to stage five, with 1 for preadolescent and 5 for mature/adult.
- Secondary Outcome Measures
Name Time Method Time to Subsequent Anticancer Therapies Up to 15 years Time to subsequent anticancer therapies will be assessed only per regulatory request or sponsor needs.
Survival Status Assessment Up to 15 years Survival status will be assessed as the length of time from the participant's first dose date of study drug to death during the study due to any cause or last date of being alive during the study. Survival status will be assessed only per regulatory request or sponsor needs.
Percentage of Participants With Cause of Death Up to 15 years Overall Rate of Replication-competent Retrovirus/Replication-competent Lentivirus (RCR/RCL) Up to 15 years Percentage of Participants With Vector Integration Site(s) for Replication-competent Retrovirus/Replication-competent Lentivirus (RCR/RCL) or Insertional Mutagenesis for Confirmed Events Related to the Cell Therapy Product Up to 15 years Percentage of Participants With Status of Primary Malignant Disease Up to 15 years
Related Research Topics
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Trial Locations
- Locations (83)
Banner MD Anderson Cancer Center
🇺🇸Gilbert, Arizona, United States
City of Hope
🇺🇸Duarte, California, United States
UC San Diego Moores Cancer Center
🇺🇸La Jolla, California, United States
Children's Hospital Los Angeles
🇺🇸Los Angeles, California, United States
University of California Los Angeles
🇺🇸Los Angeles, California, United States
Children's Hospital of Orange County
🇺🇸Orange, California, United States
Stanford University
🇺🇸Palo Alto, California, United States
University of California Davis Comprehensive Cancer Center
🇺🇸Sacramento, California, United States
University of California, San Francisco Medical Center
🇺🇸San Francisco, California, United States
Colorado Blood Cancer Institute
🇺🇸Denver, Colorado, United States
Scroll for more (73 remaining)Banner MD Anderson Cancer Center🇺🇸Gilbert, Arizona, United States